ID

34375

Descripción

Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive This form contains information about detailed monitoring of Potassium and Glucose. It has to be filled in in Session 2.

Palabras clave

Versiones (1)
  1. 17/1/19 17/1/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

17 de enero de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)

Inglés

Potassium and Glucose

1 formularios  
  1. StudyEvent: ODM
    1. Potassium and Glucose
Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Day number
Descripción

The form has to be filled in once for each day.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0439228
Potassium measurement
Descripción

Potassium measurement

Alias
UMLS CUI-1
C0202194
UMLS CUI-2
C0022885
Row number
Descripción

Row number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348184
Date
Descripción

Date of Potassium measurement

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0202194
Planned relative time
Descripción

One measurement for each planned relative time. 4hrs: to be performed prior to lunch. 8hrs: to be performed prior to dinner. 12hrs: to be performed prior to supper. 24hrs: to be performed immediately prior to dosing on the following day.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0202194
Actual time
Descripción

Actual time of Potassium measurement

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0202194
Result
Descripción

Result of Potassium measurement

Tipo de datos

float

Unidades de medida
  • mmol/L
Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0202194
mmol/L
Glucose measurement
Descripción

Glucose measurement

Alias
UMLS CUI-1
C0392201
Row number
Descripción

Row number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348184
Date
Descripción

Date of Glucose measurement

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0392201
Planned relative time
Descripción

One measurement for each planned relative time. 4hrs: to be performed prior to lunch. 8hrs: to be performed prior to dinner. 12hrs: to be performed prior to supper. 24hrs: to be performed immediately prior to dosing on the following day.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0392201
Actual time
Descripción

Actual time of Glucose measurement

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0392201
Result
Descripción

Result of Glucose measurement

Tipo de datos

float

Unidades de medida
  • mmol/L
Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0392201
mmol/L
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Similar models

Potassium and Glucose

1 formularios
  1. StudyEvent: ODM
    1. Potassium and Glucose
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Day number
integer
C0750729 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Day number
Code List
Day number
CL Item
1 (1)
CL Item
3 (3)
CL Item
5 (5)
CL Item
8 (8)
CL Item
10 (10)
CL Item
12 (12)
Item Group
Potassium measurement
C0202194 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Row number
Item
Row number
integer
C2348184 (UMLS CUI [1])
Date of Potassium measurement
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
Item
Planned relative time
text
C0439564 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
Planned relative time
Code List
Planned relative time
CL Item
Pre-dose (Pre-dose)
CL Item
20mins (20mins)
CL Item
40mins (40mins)
CL Item
1hr (1hr)
CL Item
2hrs (2hrs)
CL Item
3hrs (3hrs)
CL Item
4hrs (4hrs)
CL Item
6hrs (6hrs)
CL Item
8hrs (8hrs)
CL Item
10hrs (10hrs)
CL Item
12hrs (12hrs)
CL Item
16hrs (16hrs)
CL Item
24hrs (24hrs)
Actual time of Potassium measurement
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
Result of Potassium measurement
Item
Result
float
C1274040 (UMLS CUI [1,1])
C0202194 (UMLS CUI [1,2])
Item Group
Glucose measurement
C0392201 (UMLS CUI-1)
Row number
Item
Row number
integer
C2348184 (UMLS CUI [1])
Date of Glucose measurement
Item
Date
text
C0011008 (UMLS CUI [1,1])
C0392201 (UMLS CUI [1,2])
Item
Planned relative time
text
C0439564 (UMLS CUI [1,1])
C0392201 (UMLS CUI [1,2])
Planned relative time
Code List
Planned relative time
CL Item
Pre-dose (Pre-dose)
CL Item
20mins (20mins)
CL Item
40mins (40mins)
CL Item
1hr (1hr)
CL Item
2hrs (2hrs)
CL Item
3hrs (3hrs)
CL Item
4hrs (4hrs)
CL Item
6hrs (6hrs)
CL Item
8hrs (8hrs)
CL Item
10hrs (10hrs)
CL Item
12hrs (12hrs)
CL Item
16hrs (16hrs)
CL Item
24hrs (24hrs)
Actual time of Glucose measurement
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0392201 (UMLS CUI [1,2])
Result of Glucose measurement
Item
Result
float
C1274040 (UMLS CUI [1,1])
C0392201 (UMLS CUI [1,2])
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